FDA 510(k) Application Details - K003131

Device Classification Name Pin, Fixation, Threaded

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510(K) Number K003131
Device Name Pin, Fixation, Threaded
Applicant BIOMET, INC.
AIRPORT INDUSTRIAL PARK,
P.O.BOX 587
WARSAW, IN 46581-0587 US
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Contact CAROL LAUSTER
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Regulation Number 888.3040

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Classification Product Code JDW
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Date Received 10/06/2000
Decision Date 11/02/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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